Job Description

Commissioning Engineer

The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.

Key Responsibilities:

* Develop and execute commissioning plans for new and existing equipment and systems.

* Perform equipment start-up and troubleshooting to ensure proper operation.

* Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems.

* Analyze qualification data and prepare comprehensive reports.

* Develop and execute validation protocols for processes and computer systems.

* Conduct risk assessments and gap analyses to identify critical process parameters and control strategies.

* Prepare and maintain detailed documentation, including protocols, reports, and standard operating procedures (SOPs).

* Manage multiple CQV projects simultaneously, ensuring timely completion and adherence to project timelines.

* Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM).

Requirements:

* Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.

* Experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.

* Experience with commissioning, qualification, and validation of biopharmaceutical equipment and systems (e.g., bioreactors, chromatography systems, filtration systems).

* Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements.

* Proficiency in developing and executing IQ/OQ/PQ protocols.

* Familiarity with risk-based approaches to validation (e.g., ASTM E2500)

* Experience with process validation and computer system validation.

For further information, please contact Mick directly on (phone number removed) or forward details in confidence to (email address removed)